TP 1
FDA 510(k) K844483 · Vitatron Medical BV
510(k) numberK844483
Submission
- Device name
- TP 1
- Applicant
- Vitatron Medical BV
Dieren, NL - Received
- November 19, 1984
- Decision date
- April 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRG – Programmer, Pacemaker
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3700
- Specialty
- Cardiovascular
Other 510(k)s with product code KRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | Intermedics, Inc. | 03/15/1995SE |
| K884522 | Model 5650 Optimate Personal ProgrammerKRG · Traditional | Teletronics, Inc. | 08/25/1989SE |
| K880738 | Model 2331T Patient ProgrammerKRG · Traditional | Medtronic Vascular | 11/17/1988SE |
| K882429 | Model 255A Programmer III, W/Software Revi. 4004KRG · Traditional | Tpl-Cordis, Inc. | 07/22/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | Telectronics, Inc. | 12/17/1987SE |
| K871986 | Model 5600B Programmer, PacemakerKRG · Traditional | Telectronics, Inc. | 06/24/1987SE |
| K863046 | Ultra Software Module: Model 2016KRG · Traditional | Cardiac Pacemakers, Inc. | 12/05/1986SE |
| K863045 | Programmer Model 2035/ELECTROGRAM Cable Model 6580KRG · Traditional | Cardiac Pacemakers, Inc. | 09/29/1986SE |
| K860584 | Software MODULE/2035 Prog and Astra/T Pulse GenKRG · Traditional | Cardiac Pacemakers, Inc. | 06/06/1986SE |
| K860546 | Dialog Programmer 700 - Program Version 6.37KRG · Traditional | Pacesetter Systems | 04/23/1986SE |
More from Pacesetter Systems
| 510(k) | Device | Decision |
|---|---|---|
| K854790 | Ceryx Pacemaker Models 114, 314 & 614DXY · Traditional | 08/28/1986SE |
| K844484 | Hewlett Packardt HP 85 W/ Vitatron PH1 Program HeaKRG · Traditional | 07/24/1985SE |
| K844485 | CERYX6, 611, Ceryx 3 311 & Ceryx 1 111KRG · Traditional | 04/19/1985SE |
| K840668 | Electrode Pacemaker, Perm & TempDTB · Traditional | 09/24/1984SE |
| K831860 | Generator, Pulse, Pacemaker #532DXY · Traditional | 10/27/1983SE |
| K831859 | Pacemaker Programmer #2032DXY · Traditional | 10/27/1983SE |
| K810928 | Endocardial ElectrodeDTB · Traditional | 07/02/1981SE |
| K791920 | Cardiac Pacemaker P4000 Ser. & P1000DXY · Traditional | 11/29/1979SE |
| K791921 | Cardiac Pacemaker C4000, C1000 Ser.DXY · Traditional | 10/26/1979SE |
| K791380 | Va 1000DTA · Traditional | 09/19/1979SE |
Questions and answers
When was TP 1 cleared by the FDA?
TP 1 (K844483) received a 510(k) decision of Substantially Equivalent on April 19, 1985, 151 days after the submission was received.
What is the product code of K844483?
The FDA product code is KRG – Programmer, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3700.